Fluoxetine on Motor Rehabilitation After Ischemic Stroke

NCT00657163 | Completed Phase 2

• 2 other identifiers: 0300501French PHRC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

Conditions

Ischemic Stroke; Motor Impairment

Keywords

Stroke recovery; Pharmacological modulation; Selective Serotonin Reuptake Inhibitor (SSRI); Fluoxetine; Brain plasticity; Ischemic Stroke and Motor impairment; Modulation of recovery and cerebral plasticity by Fluoxetine

Outcome Measures

Primary Outcomes (1)

• Progression in the Fugl-Meyer Motor Scale

  M3 (3 months)

Secondary Outcomes (5)

• Fugl-Meyer Stroke Scale

  M12 (12 months)

• NIH stroke scale

  M3 and M12

• MADRS depression scale

  M3 and M12

• Modified Rankin scale

  M3 and M12

• Mortality

  M3 and M12

Study Arms (2)

1

EXPERIMENTAL

fluoxetine

Drug: fluoxetine

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

fluoxetine DRUG

fluoxetine per os 20 mg daily

Also known as: PROZAC

1

placebo DRUG

placebo per os daily

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged from 18 to 85
• No motor relapse from a previous stroke
• Ischemic stroke with unilateral motor deficit
• Motor NIHSS ≥ 5 on the affected side of the body
• NIHSS \< 20
• Fugl Meyer Motor Scale \<55
• Modified Rankin Scale between 1 and 5
• Informed consent obtained from the subject or a member of his family

You may not qualify if:

• Pregnant or breast-feeding woman
• Woman able to procreate without valid contraception
• Subject protected by law
• Concomitant disease with unfavourable prognosis within 1 year
• Drug addiction
• Allergy to fluoxetine
• Hepatic failure (TGO and TGP \>2N)
• Permanent Renal failure (Creatinin \>180micromol/l)
• Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
• Depression requiring pharmacological treatment
• Previous stroke with motor relapse
• Fugl Meyer Motor Scale \> 55
• Modified Rankin Scale = 0 or 6
• Patients needing carotid surgery within 3 months
• Aphasia preventing correct evaluation of motor and depression scales.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (9)

University Hospital

Besançon, 25030, France

Location

University Hospital René Dubos

Cergy-Pontoise, 95303, France

Location

University Hospital

Dijon, 21000, France

Location

University Hospital

Grenoble, 38048, France

Location

University Hospital

Nantes, 44093, France

Location

University Hospital Pitié Salpétrière

Paris, 75651, France

Location

University Hospital Sainte Anne

Paris, 75674, France

Location

University Hospital Rangueil

Toulouse, 31052, France

Location

University Hospital Purpan

Toulouse, 31059, France

Location

Related Publications (3)

• Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.

  PMID: 11761469 BACKGROUND

• Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4. doi: 10.1161/01.str.27.7.1211.

  PMID: 8685930 BACKGROUND

• Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.

  PMID: 21216670 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• François Chollet, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 16, 2011

Record last verified: 2009-07

Locations

FR (9)